Ministerial Ordinance amending electronic document storage rules under health ministry laws
医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律等の一部を改正する法律の一部の施行に伴う厚生労働省関係省令の整備等に関する省令
Published: 2026-09-30 · Source: e-Gov Law Search — Updated Laws · Stage: Scheduled to Take Effect · Area: Healthcare / Pharmaceuticals · Impact (preliminary): Medium · First detected by this dashboard: 2026-10-17
View the original Japanese source More Healthcare / Pharmaceuticals updates Search all updates in the dashboard
AI summary
Generated by AI from the Japanese source metadata. It is an unofficial monitoring aid, not legal advice, and may contain errors. The area, stage, and impact labels are preliminary keyword-based triage labels. Confirm every point in the original Japanese source.
Summary
Ministry of Health, Labour and Welfare Ordinance No. 142 of 2026 was promulgated on 2026-09-30, with a stated effective date of 2027-05-20, to adjust ministry ordinances following partial implementation of an Act amending legislation on the quality, efficacy and safety of pharmaceuticals and medical devices. The listed amendment concerns the Ordinance on the Use of Information and Communications Technology in Document Preservation by Private Businesses and Others under Laws Administered by the Ministry of Health, Labour and Welfare (Ministry of Health, Labour and Welfare Ordinance No. 44 of 2005).
Business Impact
Private businesses and others preserving documents under laws administered by the Ministry of Health, Labour and Welfare may be affected through changes to electronic document storage rules. The listed target is this document-preservation ordinance, rather than pharmaceutical or medical-device requirements generally; the specific changes are not provided.
Recommended Action
Review the official Japanese amendment for the affected electronic document-preservation provisions, their scope and the stated 2027-05-20 effective date.
Timeline of related official records
Related official records are linked only when names and instrument numbers match exactly, so this timeline may be incomplete. Dates are as stated by the official sources. It is a monitoring aid, not legal advice; the original Japanese sources are authoritative.
- 2026-09-30 — Promulgated (instrument recorded by e-Gov Law Search) Original Japanese source
- 2027-05-20 — Effective date stated by e-Gov Law Search Original Japanese source